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This workshop will gather experts from industry, academia and government to discuss various aspects of new antibacterials development including clinical and regulatory challenges. Attendees will also learn about funding opportunities provided by the US government for discovery/development of new antibacterials.

  • Learn about the pipeline of antibacterial therapeutics
  • Discuss challenges in setting the PK/PD targets for definition of clinical dosing
  • Discuss regulatory guidance and strategy for development of new antibacterials
  • Gain insight into the challenges in clinical development of new antibacterials from the industry’s perspective
  • Learn about US Government funding opportunities

Workshop LEADER

keynote-img

Tina Guina

Therapeutics Development Project Officer, NIAID

Dr. Tina Guina is a Therapeutics Development Project Officer at the National Institute of Allergy and Infectious Diseases (NIAID). Dr. Guina has twenty-five years of experience in infectious disease research and product development in academia, industry and government. Research and development topics included studies of various Gram-negative bacteria, development of anthrax, influenza and tuberculosis vaccines, and animal models to gain approval of vaccines and drugs under Animal Rule. Currently, Dr. Guina manages NIAID contracts awarded for development of antibacterial therapeutics. She is a principal investigator of the working group for the qualification of primate model of pneumonic tularemia, and a co-chair/member of the US Government committees on biodefense preparedness and response

NIAID

The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports research - at the National Institutes of Health (NIH), throughout the United States, and worldwide - to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov

Workshop programme

13:30 Registration

14:00 Opening remarks and introductions

Tina Guina

Tina Guina, Therapeutics Development Project Officer, NIAID
View Bio

Francois Franceschi

Francois Franceschi, Therapeutics Development Program Officer, NIAID

14:05 Novel antibacterial therapeutics pipeline

Francois Franceschi

Francois Franceschi, Therapeutics Development Program Officer, NIAID

  • Overview of pipeline with focus on new classes of antibacterial antibacterial therapeutics
  • 14:20 PK/PD targets for novel antibacterials

    Thomas Lodise

    Thomas Lodise, Professor, Pharmacy Practice, Albany College of Pharmacy and Health Sciences

  • Methods for determination of PK/PD targets for clinical dosing
  • Challenges in determination of PK/PD for new classes of antibacterials
  • 15:00 Regulatory considerations for development of new antibacterials

    Ian Friedland

    Ian Friedland, Chief Medical Officer, Achaogen

  • Summary of the FDA and EMA guidance on regulatory pathways for approval of new antibacterials and harmonization
  • Overview of FDA workshop ‘Facilitating Antibacterial Drug Development for Patients with Unmet Need’
  • 15:45 Coffee

    16:00 Challenges in clinical development of novel antibacterials – industry perspective

    John Tomayko

    John Tomayko, Chief Medical Officer, Spero Therapeutics

  • Overview of clinical development pathways 
  • Operational challenges and lessons learned
  • 16:45 The US government funding opportunities

  • Overview of funding opportunities from early research and development through late stage clinical development
  • Christopher Houchens

    Christopher Houchens, Branch Chief, Antibacterials Program, BARDA

    Tina Guina

    Tina Guina, Therapeutics Development Project Officer, NIAID
    View Bio

    17:00 Discussion

    Tina Guina

    Tina Guina, Therapeutics Development Project Officer, NIAID
    View Bio

    Francois Franceschi

    Francois Franceschi, Therapeutics Development Program Officer, NIAID

    John Tomayko

    John Tomayko, Chief Medical Officer, Spero Therapeutics

    Christopher Houchens

    Christopher Houchens, Branch Chief, Antibacterials Program, BARDA

    17:30 End of workshop

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    FEATURED SPEAKERS

    Christopher Houchens

    Christopher Houchens

    Branch Chief, Antibacterials Program, BARDA
    Francois Franceschi

    Francois Franceschi

    Therapeutics Development Program Officer, NIAID
    Ian Friedland

    Ian Friedland

    Chief Medical Officer, Achaogen
    John Tomayko

    John Tomayko

    Chief Medical Officer, Spero Therapeutics
    Thomas Lodise

    Thomas Lodise

    Professor, Pharmacy Practice, Albany College of Pharmacy and Health Sciences

    Christopher Houchens

    Branch Chief, Antibacterials Program, BARDA
    Christopher Houchens

    Francois Franceschi

    Therapeutics Development Program Officer, NIAID
    Francois Franceschi

    Ian Friedland

    Chief Medical Officer, Achaogen
    Ian Friedland

    John Tomayko

    Chief Medical Officer, Spero Therapeutics
    John Tomayko

    Thomas Lodise

    Professor, Pharmacy Practice, Albany College of Pharmacy and Health Sciences
    Thomas Lodise

    Tina Guina

    Therapeutics Development Project Officer, NIAID
    Tina Guina

    Dr. Tina Guina is a Therapeutics Development Project Officer at the National Institute of Allergy and Infectious Diseases (NIAID). Dr. Guina has twenty-five years of experience in infectious disease research and product development in academia, industry and government. Research and development topics included studies of various Gram-negative bacteria, development of anthrax, influenza and tuberculosis vaccines, and animal models to gain approval of vaccines and drugs under Animal Rule. Currently, Dr. Guina manages NIAID contracts awarded for development of antibacterial therapeutics. She is a principal investigator of the working group for the qualification of primate model of pneumonic tularemia, and a co-chair/member of the US Government committees on biodefense preparedness and response

    Renaissance Woodbridge Hotel

    515 US Highway 1 South
    Iselin 08830
    USA

    Renaissance Woodbridge Hotel

    Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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